Project title: Effective and safe interventions for prevention of malaria in pregnancy in India: an assessment of burden of malaria in pregnancy, the efficacy and implementability of a screening strategy and barriers to scaling up interventions.
Principal Investigators: Dr Neena Valecha (India) and Prof Daniel Chandramohan (UK)
Co-Principal investigators: Dr Anupkumar Anvikar (India) and Prof Feiko ter Kuile (UK)
Dr Neelima Mishra (Rourkela, India), Dr B Shahi (Ranchi, India), Ms I Kupfer (UK), C Drakeley (UK) Ms J Bruce, Ms J Webster (UK), Prof B Greenwood (UK)
Ranchi, Jamshedpur, and Rourkela
Available data on the epidemiology of MiP, and efficacy, safety and cost-effectiveness of potential interventions to control MiP in India are inadequate to recommend evidence based policies.Thus, we propose to generate the information needed to develop an evidence-based, effective national MiP control programme. The study aims to determine the efficacy and implementability of intermittent screening and treatment (IST) compared to passive case detection and management (PCD) on the risk of placental malaria and its consequences. This is a cluster randomized, controlled trial with two arms undertaken among pregnant women of all parities. In the control arm (the PCD group), at each focused ANC visit women with a history of fever in the past 48 hourstemperature ≥ 37.5°C will be tested for malaria using a rapid diagnostic test (RDT) and if positive for malaria women will be treated with artesunate (AS) + sulphadoxine pyremithamine (SP).In the intervention arm (IST group), at each focused ANC visit all women will be screened for malaria with an RDT whether a woman has a history of fever or not and if the RDT is positive for malaria women will be treated with AS+SP, as in the control arm.From all women whenever an RDT is done, blood slides and filter paper samples will also be collected for testing for malaria.Women who default the appointment for ANC visits will be followed up at home and encouraged to attend ANC.
The study will be conducted in three sub-districts (Kamdara, Basia and Palkot), Gumla district, Jharkand State in India. The sample size of 3100 women from 31 clusters per arm would have 80% power and 95% precision to detect a 25% difference between the groups assuming that the risk of placental malaria in the PCD group will be 7.5% and the coefficient of variation in the risk of placental malaria between clusters will be <0.1.
This trial started in October 2010 and is expected to be completed by March 2013.